Warehousing of medicinal products

1. WAREHOUSING
Warehouse: Place where raw material or finished products are stored
before their distribution to ensure quality, safety, efficacy.
Good warehousing Practices GWP: storage of supplies so that products
are always available in good condition. It is an operation that
preserves the integrity of drugs. Written procedure: describe the
storage conditions of drugs, temp. humidity, light required
IMPORTANCE OF Good warehousing Practices GWP:
 Optimizes resources for large scale storage in specified manner
 Integral part of supply chain
 Save time/effort to identify & locating products
 Controls the movement & storage of material in stores
 Helps easy stock take, stock verification & stock corrections
 Concept of zone product wise segregation
 Streamline the process of retrieval, storage & distribution
 Regulatory requirement for Pharmaceuticals

2. WAREHOUSING
 Good warehousing Practices: Warehousing & storage is an act of
storage & assorting finished goods so as to create maximum
time utilization at minimum cost. Key activities are
 Receiving
 Identifying
 Holding
 Assembling & processing of orders to meet demand
Functions of warehousing:
1. Receiving & recording of Goods: Responsibility of Ware
house dept. to check & verify goods by weighing the shipper
coming in and counting the same at the time of receipt. &
record. Person transferring and person receiving should sign
2. Storage: Stored such that it is easy to identify as per category.
Zone concepts are good.

3. WAREHOUSING
 Functions of warehousing:
3. Order Picking: Once order has been received, line manager must
ensure to pick same order as indicated in picking list & same
batch number should be mentioned on all documents like:
invoice, picking list, delivery note etc.
4. Distribution: Line managers hand over goods to the packers who
verify goods against the delivery note & mark on shippers as per
customer. Loading supervisors must check vehicle & confirm by
matching the requirements, clean, tidy loading.
ELEMENTS OF GOOD WAREHOUSING PRACTICES:
1. Cost involved in warehouse: follow First expiry first out (FEFO)
for finished goods, provides maximum shelf life to inventory.
2. Stock verification: Ordered, timely, frequent stock verification
gives correct stocks. Non moving, dead stock, near expiry
products data must be shared with supply chains, planning dept.
to decide the strategy.

4. WAREHOUSING
ELEMENTS OF GOOD WAREHOUSING PRACTICES:
3. Safety: Occupational Health & safety assessment series
(OHSAS 18001), British standards, protective garments PPE,
helmets, safety shoes, garments, masks are essential. Warehouse
employees should be disciplined. Fire end emergency & exit
plans & fire drill need to made to validate the exit plan. Pest
control activities, rodent baits must be checked regularly.
4. Premises, Health, Hygiene : Area must be Clean, free from
smoke, dust, contaminants, ventilated, must protect goods from
adverse weather, Floors must be non slip, even etc. walls to be
smooth, impervious, durable etc., ceiling, doors, adequate light,
toilets, storage conditions for cold storage 2-8 °C, No
overloading, cleaning equipments at appropriate places etc.
5. Good documentation : Documentation of all activities done.
SOP records, Bin card, checked, updated, followed, maintain
invoices, delivery notes, other docs.

5. WAREHOUSING
CHARACTERISTIC OF GOOD WAREHOUSING
1. Systematic storage of various categories of materials/products
2. Storage of each material/product at specific place
3. Proper cleaning & sanitation
4. Control of air, light, temperature & humidity
5. Safety measures for warehouse staff & stocked goods
6. Clear labeling of products stored on the shelves
7. Protection against pests and rodents
8. Separate stock card for each material
9. Storage of hazardous, poisonous and flammable/explosive
materials in separate places.

6. WAREHOUSING
1. Warehousing staff: Pharmacist- stock mgt. safety, preservation
of stock. Receiving, storage, issue, maintain stock are the
duties. Workers of warehouse- handling operations, carrying &
moving the stock for storage, shipment & sale. Cleaners:
cleanliness of premises, equipments of handling. Security staff:
for security of warehouse.
2. Warehousing of raw & packaging materials
3. Warehousing of intermediate & bulk products
4. Warehousing of finished products: key requirements:
a) Adequate number of qualified & trained staff
b) Regular cleaning & sanitation of the warehouse areas
c) Sufficient capacity area to store, quarantine, releasing, rejected,
returned, recalled products
d) Temperature & RH

7. WAREHOUSING
e. Clear labeling & marking over storage containers for quick
identification & controlled stock movement
f. Effective pest and rodent control
g. Periodic stock reconciliation
h. Store rotation based on First in first out (FIFO) basis
i. Proper documentation for storage, handling & transportation of
stock.

8. MATERIAL MANAGEMNET
It is concerned with Planning, organizing, controlling the flow of
materials from their initial purchase through internal operations to
the final stage of production and service point by distribution.
Objectives:
Gains economy in purchasing
Satisfy demand during period of replenishment
Carry reserve stock to avoid stock out
Stabilize fluctuations in consumption
Provide reasonable level of client services
Have adequate materials in hand when required
Minimize the inventory investment
Operate efficiently
Pay lowest possible prices, consistent supply & value requirement
for purchase materials.

9. MATERIAL MANAGEMNET
Principles of Material Management :
1. Effective management & supervision: It depends of managerial
functions of Planning, Organizing, Staffing, directing,
controlling, reporting, budgeting
2. Sound purchasing methods
3. Skillful & hard poised negotiations
4. Effective purchase systems
5. Must be simple
6. Must not increase other costs
7. Simple inventory control programs

10. MATERIAL MANAGEMNET
FUNCTIONS OF MATERIAL MANAGEMENT DEPARTMENT
1. Materials planning: Basic function of the materials Mgt
department to tell the material requirement of future and ensure
that required materials are available in time & at low cost.
2. Purchasing: Efficient & economic purchasing results in reduced
operating cost & adds to profits
3. Procurement of quality materials: Main function of materials
department to ensure that only materials of standard quality should
be procured
4. Lower inventories: If inventories are kept low, less capital is
required in inventories and results in gaining profits
5. Regular supply: For uninterrupted production continuous supply of
materials is must, hence controls production cost.
6. Efficient handling: By using effective material control techniques
production cost can be lowered

11. MATERIAL MANAGEMNET
FUNCTIONS OF MATERIAL MANAGEMENT DEPARTMENT
7. Efficient production scheduling: The dept. helps in efficient
scheduling of production by ensuring availability of required
materials in a timely manner
8. Specifications & standardization of materials: The dept. prepares
specifications and standardizes the materials.
9. To take make or buy decisions: The materials dept. reviews cost
& availability of materials on regular basis & can conclude
whether it is economic to purchase the materials or to
manufacture self.
10. Enhancement of firm’s goodwill: This is also one of the
functions of the depart. To maintain good relations with the
suppliers of materials, that increases firms goodwill in business
community.

12. MATERIAL MANAGEMNET
FUNCTIONS OF MATERIAL MANAGEMENT DEPARTMENT
11. Product design & development: Materials dept. also assists in
product design & development.
12. Co-ordination with other departments: Efficient working of
materials department is essential for the success of every other
dept. in the organization. The success of Materials dept also
depends upon how effectively it coordinates with the staff of
other dept.
13. Manpower development: Material dept. devotes efforts in
locating, training & developing talented personnel who can take
responsibilities of the business relating to materials management
in future.

13. STAGES OF MATERIAL MANAGEMNET
1. General controls: Follow written procedures for Receipt,
identification, storage, quarantine, testing & approval/rejection
of materials. Manufacturers of critical materials used in Mfg
should be evaluated properly. If suppliers of material is not the
Mfg of that material the name, address of Mfg. should be
disclosed by the supplier.
2. Receipt and Quarantine: On receiving & before acceptance,
each container of material should by be examined for labeling,
container damage, broken seals or evidence of any tampering or
contamination. It should be checked that received consignment
corresponds to the order placed. Unique code/batch or receipt
no. should be allotted to identify the containers. While
disposition of materials the unique code allotted should be
recorded. The incoming material is stored under quarantine.

14. STAGES OF MATERIAL MANAGEMNET
3. Sampling & testing of incoming materials: Release of
materials should be done only after proper testing. For
Materials received from new suppliers, three batches should be
analysed and the results must be comparable with the certificate
of analysis supplied. This is known as in house verification.
Sampling to be conducted as per defined sampling plan which
includes sample size, number of containers to be sampled,
which part of container to be sampled. Containers from which
samples are taken must be marked.
4. Storage & issue of materials: Proper storage prevents
degradation, contamination, and cross contamination of
materials. Any damage to be recorded, informed to QC dept.
Materials should be kept in drums, bags, boxes or racks/shelves
above ground to allow proper cleaning and inspection. Storage
at req. temp., relative humidity etc.

15. STAGES OF MATERIAL MANAGEMNET
Rejected materials if any must be quarantined separately. Receipt &
issue of each lot of material should be entered properly in the
stock register/ card. Issue of materials should be made only
upon written request. Hazardous material under supervision of
responsible person.
5. Returned Goods: identified Reasons of return, isolation on
receipt, must be maintained in writing. QC manager to examine
for any reprocessing or destruction procedures & instruct
accordingly.
6. Re evaluation: Materials should be re evaluated/ retested at
proper intervals to determine their suitability for use.